A Pre-market, Prospective, Comparative, Concept Proofing, Study Evaluating if Mothers Who Are Both Breastfeeding and Pumping in the First Days After Delivery Report Improved Comfort Levels With the New Symphony Program Card INITIATE 2.0 Program Compared With the Current Standard of Care, the Symphony Plus Program Card.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Medela AG
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Occurrence of adverse events
研究概览
简要总结
The study hypothesizes that mothers who are both breastfeeding and pumping in the first days report improved comfort levels with the new Symphony program card INITIATE 2.0 compared to the standard of care.
详细描述
This study aims to investigate whether the proposed changes to the INITIATE 2.0 program card lead to an improvement in comfort during pumping as well as increased milk removal during a pumping session. The results of this study will provide important information that a) validates the proposed changes as well as b) builds clear recommendations for which vacuum level should be used for Symphony program cards in this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Subject ≥ 18 years old
- •Infant was born maximum 4 (96 hours) days ago
- •Subject aims to provide breastmilk for the baby through breastfeeding.
- •At least 50% of the milk removal sessions in the last 24hrs were breastfeeds.
- •Subject has an indication to pump for reasons
- •The subject signs the informed consent documentation
排除标准
- •Woman is exclusively pumping
- •Woman is experiencing a mastitis event
- •Woman is still breastfeeding with the previous child
- •Woman has been breastfeeding in the last 6 months
- •Woman received morphine pain medication in the last 8 hours
研究组 & 干预措施
Standard of Care
Standard of Care
干预措施: breast pumping as per SoC but on new software for the pump (Device)
new device
new device
干预措施: breast pumping as per SoC but on new software for the pump (Device)
结局指标
主要结局
Occurrence of adverse events
时间窗: during the 20 minutes pumping procedure. this is the only visit and task for the patient.
Number of patients with adverse events \& description
Comfort while pumping
时间窗: Within the 20 minutes pumping procedure. this is the only visit and task for the patient.
Assessed by the necessity of reducing the vacuum strength during pumping (binary outcome). It is expected that mothers should not need to change the vacuum strength when using the new program card
次要结局
- Performance of the new software(during the 20 minutes pumping procedure. this is the only visit and task for the patient.)